The following data is part of a premarket notification filed by Genetic Laboratories, Inc. with the FDA for Suture Strip.
| Device ID | K842621 | 
| 510k Number | K842621 | 
| Device Name: | SUTURE STRIP | 
| Classification | Strip, Adhesive, Closure, Skin | 
| Applicant | GENETIC LABORATORIES, INC. 1385 DENTENNIAL DRIVE St. Paul , MN 55113 - | 
| Contact | Daniel G Holman | 
| Correspondent | Daniel G Holman GENETIC LABORATORIES, INC. 1385 DENTENNIAL DRIVE St. Paul , MN 55113 - | 
| Product Code | FPX | 
| CFR Regulation Number | 880.5240 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1984-07-05 | 
| Decision Date | 1984-10-25 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SUTURE STRIP  74021832  1697316 Live/Registered | Genetic Laboratories Wound Care, Inc. 1990-01-23 | 
|  SUTURE STRIP  73481080  1370707 Dead/Cancelled | GENETIC LABORATORIES, INC. 1984-05-21 |